Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers
Status:
Not yet recruiting
Trial end date:
2025-01-31
Target enrollment:
Participant gender:
Summary
Background:
People with HIV take drugs to keep the amount of virus in their body low. One type of these
drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time.
Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to
understand how INSTIs cause weight changes.
Objective:
To see how a common INSTI, dolutegravir (DTG), affects how the body uses energy. DTG will be
compared with a non-INSTI drug, tenofovir alafenamide (TAF).
Eligibility:
Healthy people aged 18 to 55.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have
a nutritional assessment and tests of their heart function.
Participants will have 2 inpatient stays at the clinic. Each stay will be for 11 nights, with
a 3-week break between.
Both DTG and TAF are gel caps swallowed once per day by mouth. Participants will take 1 drug
for 8 days during each stay.
Participants will have tests to see how their body uses energy:
They will spend 23 continuous hours in a special room that measures how much oxygen they
breathe in and how much carbon dioxide they breathe out. They will do this a total of 6
times.
They will have a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that
measures body fat and bone density.
They will lie on a table. Electrodes will be placed on their hands and feet to measure body
fat and lean body mass.
They will stand still on a platform for about 30 seconds. High-resolution laser cameras will
scan their bodies.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)